P03 - Attachment 1 Exception to Fair Opportunity DC.pdf

Attachment 1: Request for Exception to Fair Opportunity Memo Format

Effective Date: 03/15/2023 Revision: 02

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval

For Exception to Fair Opportunity Memo

Acquisition Plan Action ID: 36C250-26-AP-0275

1. Contracting Activity:

Department of Veterans Affairs, VISN 10, Station 583, Roudebush VA Medical Center, submitted to Network Contracting Office (NCO) 10 located at 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200, Ann Arbor, MI 48105, procurement request for Medtronic O-Arm and StealthStation Services.

The funding request for this requirement is through PR-IFCAP 583-26-2-169-0017 in the amount of $212,585.00.

2. Description of Action:

The estimated value of the proposed action is: $637,755.00, one (1) base year and two (2) option years.

Contractor shall provide one (1) annual preventative maintenance and all corrective maintenance, including all parts, labor, supervision, test equipment, technical manuals, transportation, software upgrades and maintenance, and remote support, on one (1) Medtronic O-arm (S/N: C2502) and two (2) StealthStations (S/N:

N30067136 and N30072628) located at Richard L. Roudebush VA Medical Center, 1481 W 10th Street, Indianapolis, IN 46202.

3. Description of Supplies or Services:

Contractor shall provide all software licenses, maintenance, and upgrades for equipment. The Contractor shall perform one (1) scheduled annual preventive maintenance on all Medtronic equipment covered during the contract year. Maintenance shall be completed with a one (1) hour initial response and an eight (8) hour on-site response time after request by the department, COR, or designee within the defined Hours of Work. All services provided under this contract must be performed in accordance with the OEM and Occupational Safety and Health Administration (OSHA) standards and specifications. Below is a list of equipment anticipated to receive these services:

Serial # System Type Part Number C2502 O-Arm O2 SERVICEC1 - O2MCT10 N30067136 S8 with EM SERVICEC1 - S8MCT21 N30072628 S8 with EM SERVICEC1 - S8MCT21

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C.

4106(c) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i):

(N/A) FAR 16.505(b)(2)(i)(A): The agency's need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

( X ) FAR 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

(N/A) FAR 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(N/A) FAR 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee.

Effective Date: 03/15/2023 Revision: 02

(N/A) FAR 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source”. The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program, which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business (VOSB).

5. Rationale Supporting Use of Authority Cited Above:

Medtronic Products are complex medical devices subject to regulation by the Food and Drug Administration. As such, Medtronic does not authorize the repair or service of these Medtronic Products by customers or third parties, including the loading or reloading of software, and does not authorize any customers or third parties to perform service or repair. Medtronic cannot guarantee the proper performance or results of its systems following any unauthorized service, repair, or modification to these Medtronic Products, and any unauthorized service, repair, or modification will void existing warranties and service agreements.

6. Efforts to Obtain Competition: A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable.

Market research was conducted. In addition, the original contract was solicited via SPE2Dl-15 -R- 0001.

7. Actions to Increase Competition: Describe actions taken, or that will be taken, to remove or overcome any barriers to competition before initiating any subsequent acquisitions for the supplies or services required, including challenges to restrictive data markings, data rights, preparation of a performance-based work statement, etc.

Market analysis will be performed by utilizing VetCert, SBA DSBS, GSA, AbilityOne, HTME pre-existing contracts, and reviewing the current contract servicing the contract. This is to ensure potential sources are identified in order to determine the appropriate type and degree of competition. This service can only be provided by a Medtronic-certified technician.

8. Market Research: Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. When citing FAR 16.505(b)(2(i)(b) or FAR 16.505(b)(2)(i)(e), the only possible way to state in paragraph 5 of the J&A that there is only one contractor who can fulfill the agency’s needs is to conduct market research, and it should be summarized here.

• A Small Business Search (SBA) was completed using NAICS 423450 and the search term ‘O-arm’. No results returned from this search.

• The current services are being covered under Contract No. SPE2D1-19-D-0018, Task Order No.

36C25023F0409. Task Order No. 36C25023F0409 has a period of performance of 03/01/2023 through 02/28/2026 with an aggregate total of $657,871.00. This task order was awarded to Medtronic, Inc., Large Business. The CO confirmed Contract No. SPE2D1-19-D-0018 is valid until 06/03/2029. This would cover the duration of the new procurement.

• A GSA eLibrary search was completed using the search term ‘O-arm’. No viable contracts returned from this search.

• The AbilityOne Services List was reviewed. None of the services listed are compatible with the services needed.

• The High Tech Medical Equipment (HTME) webpage with Pre-existing contracts was reviewed. Contract No.

SPE2D119D0018 was discovered and contains the services required for this procurement. Contract No.

SPE2D119D0018 is valid until 06/03/2029.

Effective Date: 03/15/2023 Revision: 02

• The Original Equipment Manufacturer (OEM) has provided a letter stating, ‘Medtronic does not sell or authorize the sale of parts to third-party service/repair companies. Medtronic cannot guarantee the proper performance or results of its systems or Medtronic Products if unauthorized or non-OEM parts have been used, and is not responsible for the cost to bring any adulterated Medtronic Products back to manufacturer’s specifications.’

9. Other Facts:

The services requested are currently being covered under Contract No. SPE2D1-19-D-0018, Task Order No.

36C25023F0409. Task Order No. 36C25023F0409 has a period of performance of 03/01/2023 -02/28/2026. This Task order contained two (2) option years, with an aggregate total of $657,871.00. This task order was awarded to Medtronic, Inc., Large Business. The CO confirmed Contract No. SPE2D1-19-D-0018 is valid until 06/03/2029.

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Anne Cunningham Biomedical Engineer Richard L. Roudebush VA Medical Center

11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable:

The pricing contained in Contract No. SPE2D1-19-D-0018 has already been deemed fair and reasonable for the services required.

12. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Andrea J. Roach Contracting Officer Network Contracting Officer (NCO) 10 Services Team 3

13. Approvals in accordance with VHAPG Part 816.505 Indefinite Delivery Contracts: Ordering.

a. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Toni Waggoner-Boykin Division Chief, General and Healthcare Services Network Contracting Office (NCO) 10 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPG/VHAPG_Part_816.505.aspx